Evaluation of Surgical Stress Index (SSI) During Sevoflurane/Remifentanil Anesthesia

June 14, 2012 updated by: Berthold Bein, University Hospital Schleswig-Holstein
The aim of the present prospective randomized study was to challenge the ability of SSI to detect painful stimulation during sevoflurane - remifentanil anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

General anesthesia can be considered as a combination of hypnosis, antinociception and immobility. Whereas monitoring of depth of hypnosis, and muscle relaxation can be regarded as accepted, determination of the nociception is based on clinical signs like somatic or autonomic responses.

Recently, the multivariate surgical stress index (SSI)has been demonstrated to correlate with surgical stress intensity. Thus, SSI might be a useful variable to adjust analgesic drug administration in individual patients.

We want to investigate whether SSI is able to indicate nociception following standardized noxious stimulation during balanced sevoflurane - remifentanil anesthesia.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • SH
      • Kiel, SH, Germany, D-24105
        • Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age between 18 and 65 years
  • ASA physical status 1-2
  • elective surgery in general anesthesia of 1 to 2 hours
  • written informed consent

Exclusion Criteria:

  • pregnancy
  • history of cardiac arrhythmia
  • presence of any neuromuscular or neurological disease
  • use of CNS-active medication or abuse of alcohol or illicit drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
increasing remifentanil administration
Procedure: standardized pain stimulus
a tetanic stimulus (30s, 50 Hz, 60mA) applied as standardized pain stimulus
Other: 2
decreasing remifentanil concentration
Procedure: standardized pain stimulus
a tetanic stimulus (30s, 50 Hz, 60mA) applied as standardized pain stimulus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SSI, compared to standard monitoring variables
Time Frame: during anesthesia
during anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Matthias Gruenewald, MD, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
  • Study Chair: Berthold Bein, MD, DEAA, Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

November 14, 2008

First Submitted That Met QC Criteria

November 14, 2008

First Posted (Estimate)

November 17, 2008

Study Record Updates

Last Update Posted (Estimate)

June 15, 2012

Last Update Submitted That Met QC Criteria

June 14, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SSI-134-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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